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The Current State of UDI

We held the April GHX Global Data Standards User Group Meeting on-site at the 2017 Healthcare Supply Chain Summit in National Harbor, MD on April 26, 2017. As always we had a tremendous turnout with individuals from throughout the healthcare supply chain continuum - providers, suppliers, GPOs, distributors — engaging in constructive dialogue on how to drive greater data standardization within our industry.

Terrie L. Reed, senior advisor for UDI Adoption at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), spoke at the event, offering an update on the FDA’s Unique Device Identification (UDI) initiative, and how they are working with other government agencies and industry organizations on collaborative ways to leverage UDI in an effort to drive value throughout healthcare – for providers, manufacturers, researchers and patients. Here are some of the initiatives Reed described:

Medical Device Innovation Consortium (MDIC) National Evaluation System for health Technology (NEST): This is a private/public partnership that is working to assemble a national evaluation system for medical devices. NEST would compile and amalgamate data on the performance of medical devices throughout their lifecycles from a variety of sources — clinical registries, electronic health records and medical billing claims. This system would help support regulatory and clinical decision-making. Reed noted that NEST will have demonstration projects that include data from the Global UDI Database (GUDID).

Medical Product Safety Network (MedSun): This is the CDRH’s adverse event reporting program where approximately 300 hospitals, nursing homes and home health facilities collect real-world information about device adverse events. The website now includes UDIs for the reported devices. Furthermore, when a healthcare facility reports an adverse event, the MedSun website auto populates the device’s UDI from the GUDID, when the UDI is available.

MDIC Case for Quality (CfQ) Product Quality Outcomes Analytics Working Group: This multi-disciplinary group, comprised of representatives from manufacturers, providers, FDA, and value analysis committees (VACs), is working to establish standardized medical device performance data and analytics that healthcare provider organizations can use to inform purchasing decisions. They are currently working to incorporate UDIs into the data set.

Association for Healthcare Resources and Materials Management (AHRMM) Learning UDI Community (LUC): The FDA has been actively involved in AHRMM’s LUC, which is a broad-based coalition comprised of healthcare leaders across sectors whose goal is to develop a common understanding and approach to UDI adoption within the healthcare setting.

International Medical Device Regulatory Forum (IMDRF): This is a voluntary group of medical device regulators from around the world (including the FDA) who are working together to accelerate international medical device regulatory harmonization and convergence. One of the IMDRF work items is to harmonize medical device standards for regulatory use. The group issued a UDI Guidance Document for the Unique Device Identification of Medical Devices in 2013. On April 5, 2017, the European Union (EU) issued its new Medical Device Regulations (MDR), so Reed notes that it is now time for IMDRF members to revisit global implementation of UDI.

To stay on top of the latest developments in healthcare data standards, be sure to attend the GHX Global Standards User Group, which meets online 4-6 times per year, typically on the third Thursday of the month at 10:00 AM ET. To receive email notifications for upcoming meetings, or if you have questions or suggestions, email GHXStandardsUG@ghx.com.